Applying for general release or release with controls

Preparing to make an application

The following guidance is given for the development and preparation of an
application to the EPA to import for release, or release from containment, or
release with controls predators, parasitoids, herbivores or pathogens for the
purpose of biological control of a plant, animal or disease. This advice does
not apply to genetically modified new organisms, or to introduction of a new
organism under emergency, or to the introduction of any material for medical or
veterinary purposes.

In the course of introducing a new biological control agent, the applicant may
need to import the organism into
containment
for further evaluation of efficacy of the biological control agent, and
host range specificity testing.

In order to determine whether the organism proposed for introduction is
indeed a new organism, applicants should refer to the EPA web page
.
It is also possible to submit an application to
or not.

The steps in the process of applying for approval to introduce a new
biological control agent for general release (with and without controls) are as
follows:

Selection of the biological control agent

Pre-application consultation with

EPA staff

DOC

MPI

Maori

Other stakeholders and interest groups

Preparation for an application

Identification and assessment of risks and benefits

Formal receipt of application

Post-application processes

Public submissions on the application

Staff assessment report (report prepared by the EPA)

Public hearing (if required) before the Authority

Consideration by decision-making committee

Decision

Notification of Decision

As much as the content of the proposal is important, it is the quality of the
process by which the application is prepared that will give the EPA
confidence that the applicant has addressed all relevant factors. Gaining that
confidence is likely to reduce statutory delays and ensure the rapid evaluation of the
proposal. For that reason, it is important for applicants to be thorough, frank,
open and inclusive when assembling the information that EPA
requires. The first step in preparing an application should be to
contact an EPA New Organisms Advisor [http://www.epa.govt.nz/Contact-us/Pages/Contact-us.aspx]
and develop a dialogue.

For most applications to import a new organism the primary concern is the
risk that the organism will form an unwanted population in New Zealand, that
will have adverse environmental effects.

Clause 33 of the Methodology states:

"When considering an application, the Authority must have regard to the extent
to which the following risk characteristics exist:
(a) Exposure to risk is involuntary
(b) The risk will persist overtime
(c) The risk is subject to uncontrollable spread and is likely to extend its
effects beyond the immediate location of incidence
(d) The potential adverse effects are irreversible
(e) The risk is not known or understood by the general public and there is
little experience or understanding of possible means of managing the potential
adverse effects."

In accordance with clause 33 of the Methodology, the Authority is likely to
be more cautious and risk averse according to the extent to which these risk
characteristics exist.

New organisms released as biological control agents will usually exhibit all
of these characteristics because that is what the applicant intends. To become
successful, the agent must establish, populations must be self-sustaining, and
biological control agents must spread to attack the host in its entire range. In
considering risks for biological control agents, the EPA
have to balance the acceptable characteristics intended for a beneficial
biological control outcome with those risks which relate to unintended outcomes.